Cleared Traditional

K890623 - FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT

K890623 is an FDA 510(k) clearance for FLUOREVER DUAL CURE CERAMIC VENEER CEMENT, manufactured by Macrochem Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K890623 · Macrochem Corp. · Dental device
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Apr 1989
Decision
69d
Days
Class 2
Risk

K890623 is an FDA 510(k) clearance for the FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Macrochem Corp. (Billerica, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Macrochem Corp. devices

FDA 510(k) Submission Details - K890623

510(k) Number K890623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1989
Decision Date April 17, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 128d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K890623.
SILCOT COPAL CAVITY VARNISH
K895798 · Specialites Septodont · Dec 1989
KULZER GLAS-IONOMER CEMENT
K892453 · Kulzer, Inc. · Dec 1989
TEMP BOND NE
K894219 · Kerr Corporation (Danbury) · Sep 1989
CIMPAT S TEMPORARY DENTAL CEMENT
K885007 · Specialites Septodont · Mar 1989
CHELON-FIL
K884475 · Espe GmbH (Us) · Dec 1988
INTERIM, TEMPORARY CEMENT
K884081 · Scientific Pharmaceuticals, Inc. · Dec 1988